The UAE has enacted a Federal Decree-Law aimed at transforming its pharmaceutical and medical industries into a globally trusted hub.
The legislation governs all aspects of medical products, pharmacy practices, and pharmaceutical establishments, ensuring compliance with international standards while fostering investment and innovation.
The law covers a wide spectrum of medical products, including drugs, medical devices, dietary supplements, and cosmetics, alongside hazardous materials for human and veterinary use. It applies to pharmaceutical establishments such as pharmacies, manufacturing facilities, research entities, and biobanks across the UAE, including free zones.
Key provisions include streamlined licensing, monitoring, and supervision of pharmaceutical establishments by the Emirates Drug Establishment and local health authorities. The law introduces fast-track approval pathways for innovative and essential medical products, ensuring quality and safety. Additionally, it regulates pricing, advertising, and distribution, while safeguarding intellectual property through data protection mechanisms for innovative products.
For the first time, the Emirates Drug Establishment will develop and publish the UAE Pharmacopeia, setting national pharmaceutical standards. The legislation also mandates a pharmacovigilance system to monitor medical product safety and establishes national databases for medical products and facilities.
The law outlines penalties for violations, including fines of up to AED 1 million and licence revocations for severe breaches. Entities and professionals have a one-year grace period to comply, with potential extensions.
This landmark legislation underscores the UAE's commitment to enhancing pharmaceutical security and fostering a competitive, innovation-driven medical sector.
News Source: Emirates News Agency
